The following data is part of a premarket notification filed by Luther Medical Products, Inc. with the FDA for L-cath Modified Seldinger Technique Insertion/catheter Exchange Kit Pe-mst24-24 Ga. Kit, L-cath Modified Seldinger.
| Device ID | K974543 |
| 510k Number | K974543 |
| Device Name: | L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | LUTHER MEDICAL PRODUCTS, INC. 530 KINGS RD. Newport Beach, CA 92663 -5710 |
| Contact | Barbara C Luther |
| Correspondent | Barbara C Luther LUTHER MEDICAL PRODUCTS, INC. 530 KINGS RD. Newport Beach, CA 92663 -5710 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-03 |
| Decision Date | 1998-02-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20886333210071 | K974543 | 000 |
| 20886333210064 | K974543 | 000 |
| 20886333210057 | K974543 | 000 |